Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances

Abstract

Botanicals are an alternative option to prescription drugs for the alleviation of symptoms due to anxiety disorders and insomnia. Melissa officinalis L. has been shown as an anti-stress and anxiolytic agent. We previously reported moderate stress improvement in mice in which Cyracos®, a standardized Melissa officinalis L. extract, was administrated. Cyracos® contains phytochemicals that inhibit gamma-aminobutyric acid catabolism. This was a prospective, open-label, 15-day study to evaluate the efficacy of Cyracos® on stressed volunteers, who have mild-to-moderate anxiety disorders and sleep disturbances. Using clinician rating criteria, primary outcomes showed improvement of symptoms. Cyracos® reduced anxiety manifestations by 18% (p < 0.01), ameliorated anxiety-associated symptoms by 15% (p < 0.01) and lowered insomnia by 42% (p < 0.01). As much as 95% of subjects (19/20) responded to treatment, of which 70% (14/20) achieved full remission for anxiety, 85% (17/20) for insomnia, and 70% (14/20) for both. Our study demonstrates, for the first time that chronic administration of Melissa officinalis L. relieves stress-related effects. It is critical that further studies incorporate a placebo and investigate physiological stress markers.

Comparison of the Effect of Melissa officinalis Capsule and Care Educational Programs on the Intensity of Physical, Mental and Social Symptoms of Premenstrual Syndrome in High School Female Students

“…It has been argued that "the GABAergic system is a logical and promising target for new strategies to prevent and treat anxiety and its associated symptoms, such as restlessness and insomnia. GABA activity is mediated through GABAA and GABAB receptor-dependent inhibition of the CNS, and GABA catabolism relies on GABA transaminase (GABA-T) levels" (34). In addition, in our study no side effect was observed regarding taking M. officinalis capsules, which in line with other studies.…”

“…In a study, Cases et al used M. officinalis L. leaf in treating volunteers with mild to moderate anxiety disorders and sleep disorders and reported that the anxiety manifestation and insomnia decreased from 18% to 42% and 95% of the samples had responded to treatment (34).…”

“…Its main components are citral, linalool, geraniol, β-caryophyllene oxide, phenolic acid, tannins, rosmarinic acid and caffeic acid, which increase the GABA transmission contributing to the reduction of anxiety and its associated symptoms in addition to insomnia (34).…”

Effects of the single supplementation and multiple doses of Passiflora incarnata L. on human anxiety: A Clinical Trial, Double-blind, Placebo-controlled, Randomized

“…This study applied the STAI before and after within the same group evaluated (placebo or experimental). RNAm gene expression of enzymes related to the production of GABA in the hippocampus increased, although salivary markers such as cortisol and urinary such as 8-hidroxideoxiganosina stress did not change [26].…”

Comparative randomized open-label trial on efficacy and safety of Persen® and Persen® Night herbal extracts in patients with short-term insomnia

“…Необ-ходимо выделить 3 фитотерапевтических агента, наи-более исследованных и широко применямых в неврологии: валериану лекарственную (Valeriana officinalis L.), мяту перечную (Mentha piperita L.) и ме-лиссу лекарственную (Melissa officinalis L.) [9][10][11][12][13][14][15][16][17][18][19][20][21].…”